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Friday, 19 February 2016

Soybean Event Does Not Imply Sexual Crossing

The decision T915/10 relates to soybean plants and soybean seeds containing a DNA insert with the name "insertion event MON89788" which is supposed to improve the yield relative the a comparable line. The DNA can be inserted by inserting a larger section of DNA named SEQ ID NO: 9.

The board applies G 07/10 to judge wether or not claimed method is an "essentially biological process for the production of plants" pursuant to Article 53(b) EPC come to the conclusion that:

The method is defined solely by the technical process step of introducing SEQ ID NO: 9 into the genome of the plant by transformation of plant cells with heterologous DNA, i.e. a genetic engineering step introducing heterologous DNA in plant cells. The board notes that the introduced trait is due directly to the expression of the inserted DNA and is not the result of a plant breeding method characterised by crossing and selection. Indeed, the method as claimed does not require nor define steps of mixing genes of plants by sexual crossing and subsequent selection of plants, either explicitly or implicitly.

The underlined sentence above relates to the origin of the introduced trait. Does it matter if the artificially introduced trait of essentially biological origin or synthetic, i.e. if steps preceding the claimed method are essentially biological or not? The board appears to try finding the answer by drawing an analogy to "mixed" methods including crossing and selection steps and additional steps of a technical nature (emphasis added):

53. Furthermore, when considering patentability of plant breeding methods in the context of claims for methods including crossing and selection steps and additional steps of a technical nature and in contrast to the situation pertaining to processes containing a technical step which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants, the Enlarged Board of Appeal held that "[i]f, [...] such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, sothat the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under Article 53(b) EPC" (see decision G 2/07, supra, Headnote, Answer 3). This statement is considered by this board as confirming the patentability of methods for genetic engineering of plants (see decisions G 2/07 and G 1/08, supra).

Accordingly, the field of patentable genetic engineering methods outside of the realm of Art. 53(b) EPC starts where the method contains at least one step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome, irrespective of whether the preceding or subsequent steps are of essentially biological nature or what the origin of the introduced trait might be.